FSH FIA Test
Features:
-
- Quantitative, non-subjective results
- Increased sensitivity and broader detection range compared to rapid tests
- Working range: 0.30-200.00 mIU/mL
- Intra-lot Precision Intra-lot precision was determined by testing of FSH reference materials using 10 test devices from the same lot. CV ≤ 15%.
- Inter-lot Precision Inter-lot precision was determined by testing of FSH reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
- FSH control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%
- A serial concentration of FSH reference materials at 1.00-200.00 mIU/mL was tested, and the correlation coefficient (R) is ≥0.9900.
- REAGENTS AND MATERIALS PROVIDED:
- Individually sealed foil pouches containing: a. One test device b. One desiccant
- Detection buffer tubes
- SD card
- Instructions for Use
- Clock or timer
- RaFIA Immunofluorescence Analyzer
- RaFIA Immunofluorescence Incubator
| CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
F1100 |
FSH FIA Test |
25/kit |
Serum, Plasma |
H. pylori Ab Combo Rapid Test CE
Features:
- Uses serum, plasma or whole blood specimen
- No need to avoid certain medications
- Non-invasive, easy to perform procedure
- Time to result is 15 minutes
- Individually sealed foil pouches containing:
- One cassette device
- One desiccant
- Plastic droppers
- Sample diluent (REF SB-R0191, 5 mL)
- Package insert (instruction for use)
| CATALOG # | PRODUCT | QUANTOTY | SPECIMEN |
R0191C |
H. Pylori AB Combo Rapid Test CE |
30/kit |
S,P&WB |
H. pylori Ag Rapid Test CE
Features:
- Clinical accuracy: 96.7% sensitivity, 93.8% specificity
- Analytical sensitivity: 100% positive detection rate at 1 ng/mL of pylori lysate antigen in fecal specimens
- Cross reactivity: no cross reactivity with the following organisms at ≥ 1 x 108 org/mL: Acinetobacter calcoaceticus, Neisseria gonorrheae, Adenovirus, Neisseria meningitides, Enterococcus faecalis, Proteus mirabilis, Escherichia coli, Proteus vulgaris Hauser, Gardnerella vaginalis, Pseudomonas aeruginosa, Geotrichum candidum, Rotavirus, Haemophilus influenza, Salmonella Paratyphi A, α-haemolytics streptococcus, Salmonella Paratyphi B, β-haemolytic streptococcus, Salmonella Paratyphi C, Klebsiella pneumonia, Salmonella typhi, Moraxella catarrhalis
- Interference: No interference was seen with 5 mg/mL Tums® Antacid, 1:20 Pepto-Bismol® Antacid, 5 mg/mL Tagamet® Antacid, 5% Barium sulfate, 5 mg/mL Prilosec® Antacid, 12.5% Hemoglobin (tarry stool), or 1:20 Mylanta® Antacid
- Shelf life: 24 month
- Individually sealed foil pouches containing:
- One cassette device
- One desiccant
- Stool collection devices, each containing 2 mL extraction buffer
- Plastic droppers for transferring watery stool
- Package insert (instruction for use)
| CATALOG # | PRODUCT | QUANTOTY | SPECIMEN |
R0192C |
H. Pylori Ag Combo Rapid Test CE |
25/kit |
Fecal |
HbA1c FIA Test
Features:
- Quantitative, non-subjective results
- Increased sensitivity and broader detection range compared to rapid tests
- Working range: 4%–15%
- Intra-lot Precision Intra-lot precision was determined by testing of HbA1c reference materials using 10 test devices from the same lot. CV ≤ 15%
- Inter-lot Precision Inter-lot precision was determined by testing of HbA1c reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
- HbA1c control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.
- A serial concentration of HbA1c reference materials at 4%–15% was tested, and the correlation coefficient (R) is ≥0.9900.
- REAGENTS AND MATERIALS PROVIDED:
- Individually sealed foil pouches containing: a. One test device b. One desiccant
- Detection buffer tubes
- SD card
- Instructions for Use
- Clock or timer
- RaFIA Immunofluorescence Analyzer
- RaFIA Immunofluorescence Incubator
| CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
F6100 |
HbA1c FIA Test |
25/kit |
Serum, Plasma |
hCG Combo Rapid Test (strip) CE
Features:
- Clinical accuracy: In comparison with a reference chemiluminecsence or ELISA, hCG detection is
- 100% sensitivity and 100% specificity in urine specimens
- 100% sensitivity and 99.5% specificity in serum specimens
- Analytical sensitivity: 100% positive detection rate at 12.5 mIU/mL in serum/plasma specimens and 100% positive detection rate at 25 mIU/mL in urine specimens
- Analytical specificity: no cross reactivity with 1,000 mIU/mL human luteinizing hormone (hLH), 1,000 mIU/mL human follicle stimulating hormone (hFSH), and 1,000 mIU/mL human thyroid stimulating hormone (hTSH)
- Dose hook effect: no dose hook effect was observed for hCG at concentrations up to 500,000 mIU/mL in urine specimens
- Interference: No interference was seen with 35 biological and chemical analytes commonly found in OTC, prescriptions or abuse drugs in urine or serum/plasma specimens, as well as pH 4-9 (see detail in the package insert)
- Shelf life: 24 month
-
Kit box package:
1. Individually sealed foil pouches containing;
a. One dip strip device
b. One desiccant
2. One package insert (instruction for use)
Tube package:
1. Strip Package
2. One desiccant
3. One package insert (instruction for use)
| CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
R1001S |
hCG Combo Rapid Test(strip) CE |
50/kit,100/kit |
S/Urine |
hCG Combo Rapid Test CE
Features:
-
- Clinical accuracy: In comparison with a reference chemiluminecsence or ELISA, hCG detection is
- 100% sensitivity and 100% specificity in urine specimens
- 100% sensitivity and 99.1% specificity in serum specimens
- Analytical sensitivity: 100% positive detection rate at 12.5 mIU/mL in serum/plasma specimens and 100% positive detection rate at 25 mIU/mL in urine specimens
- Analytical specificity: no cross reactivity with 1,000 mIU/mL human luteinizing hormone (hLH), 1,000 mIU/mL human follicle stimulating hormone (hFSH), and 1,000 mIU/mL human thyroid stimulating hormone (hTSH)
- Dose hook effect: no dose hook effect was observed for hCG at concentrations up to 500,000 mIU/mL in urine specimens
- Interference: No interference was seen with 35 biological and chemical analytes commonly found in OTC, prescriptions or abuse drugs in urine or serum/plasma specimens, as well as pH 4-9 (see detail in the package insert)
- Shelf life: 24 month
-
- Individually sealed foil pouches containing:
a. One cassette device
b. One plastic dropper
c. One desiccant
- One package insert (instruction for use)
- Clinical accuracy: In comparison with a reference chemiluminecsence or ELISA, hCG detection is
| CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
R1001C |
hCG Combo Rapid Test CE |
30/kit |
S/Urine |
HSV-1 IgG/IgM Rapid Test CE
Features:
-
- Type-specific detection by utilizing glycoprotein G1.
- Single test that detects and differentiates IgG and IgM anti-HSV-1.
- High confidence as test is in agreement with market leading ELISA test: 90.7% IgG; 85.0% IgM.
- Flexible specimen types including serum, plasma, or whole blood which allows testing at any time without special specimen preparation.
- Small sample volume (10 µL) enables multiple testing on the same specimen without having to re-draw the patient.
- Initial treatment action can begin during the patient’s visit as test results are available in 10 minutes.
- Easily transported, and can be stored for 24 months, 2-30oC.
- Individually sealed foil pouches containing:
- One cassette device
- One desiccant
- Capillary tubes (10 µL)
- Sample diluent (REF SB-R0203, 5 mL/bottle)
- Package insert (instruction for use)
| CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
R0203C |
HSV-1 IgG/IgM Rapid Test CE |
30/kit |
S,P& WB |
HSV-2 IgG/IgM Rapid Test CE
Features:
- Unique test that utilizes glycoprotein G2 to differentiate between HSV-1. and HSV-2 that allows for an early start of treatment action.
- Immediate determination of either acute or chronic infection by detecting and differentiating IgG and IgM anti-HSV-2.
- High confidence as test is in agreement with market leading European ELISA: 95.3% IgG; 100% IgM.
- Flexible specimen types including serum, plasma, or whole blood which allows testing at any time without special specimen preparation.
- Small sample volume (10 µL) enables multiple testing on the same specimen without having to re-draw the patient.
- Initial treatment action can begin during patient’s visit as test results are available in 10 minutes.
- Easily transported, and can be stored for 24 months, 2-30oC.
- Individually sealed foil pouches containing:
- One cassette device
- One desiccant
- Capillary tubes (10 µL)
- Sample diluent (REF SB-R0213, 5 mL/bottle)
- Package insert (instruction for use)
| CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
R0213C |
HSV-2 IgG/IgM Rapid Test CE |
30/kit |
S,P& WB |
Immunofluorescence Analyzer
ACCURACY:
- Less than 3% intra-run CV
- Eliminates subjective interpretation by operator
- Results comparable to lab-based CLIA analyzer
- System uses an SD card to ensure the proper test is being run
- Able to run whole blood, serum, plasma and urine specimens
- Touch screen interface for easy operation
- Lightweight (2.9 kg) and portable
- Results presented on screen or via the built-in printer
- Storage capacity of 10,000 test results
-
SPECIFICATIONS Human Machine Interface: 4.3-inch LCD touch screen Dimensions: 280(L)×256(W)×102(H)mm Weight: 2.9 kg Power Adapter: 100-240 VAC, 50-60Hz Data output: On screen/Printer OPERATION ENVIRONMENT Temperature: 10~30℃ Humidity: ≤70% Atmosphere pressure: 85.0~106.0 Kpa Operation Altitude: ＜2000m Location: Dry, clean, flat, horizontal surface, away from direct sunlight, mechanical vibration, and strong electromagnetic interference. STORAGE ENVIRONMENTAL Temperature: 0~50℃ Humidity: ≤93% Storage Elevation: 0~2000m OPTICAL DESCRIPTION Excitation Light Source: LED 365nm Detector: Silicon photodiode
Immunofluorescence Incubator
ACCURACY:
• Incubation system control temperature variation ≤± 0.1℃
EASE-OF-USE:
• Simple temperature adjustment
• Easy incubation time-setting for each channel
• Portable and lightweight (1.4 kg)
• Incubation completion reminder chime for user convenience
• 6-channel incubator to increase throughput
| SPECIFICATIONS | |
| Dimensions: | 255(L)×135(W)×40(H)mm |
| Weight: | 1.4 kg |
| Power Adapter: | 100-240 VAC, 50 Hz, 60W |
| Temperature Setting: | 20~40℃ |
| Time Setting: | 3~30 min |
| OPERATION CONDITIONS | |
| Temperature: | 10~30℃ |
| Humidity: | ≤95% |
| Atmosphere Pressure: | 85.0~106.0KPa |
| Operation Altitude: | ＜2000m |
| STORAGE CONDITIONS | |
| Temperature: | 0~55℃ |
| Humidity: | ≤80% |
Influenza A/B Ag Rapid Test CE
Features:
- Simple test procedure
- Detection and differentiation of Influenza A and B virus, including H5N1 and H1N1
- Efficient, easy-to-interpret results
- No equipment required
- Results in only 10 minutes
- Multiple specimen collection options
- Compatibility with CTK’s Rapid Test Reader
- External Positivia controls available separately
- Individually sealed foil pouches containing:
- One cassette device
- One desiccant
- Sample extraction tubes
- Sample extraction tube rack
- Sample extraction buffer
- Nozzles with Filter
- Sterile swabs, each sealed in a plastic-paper pouch
- Instructions for Use
| CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
R0187C |
Influenza A/B Ag Rapid Test CE |
20/kit |
Swab |
Influenza A/B Rapid Test (strip) CE
Features:
- Single test that reliably detects the most common types of influenza – type A and B virus, including H1N1 (swine flu) and H5N1 (bird flu)
- High quality CE marked and approved for sale in Europe
- Comfortable and durable with a small, soft swab tip that is ideal for use with children
- Initial patient care action can begin during patient’s visit as results are available within 10 minutes
- Individually sealed foil pouches containing:
- One strip device
- One desiccant
- Sample extraction tubes, each containing 0.3 mL of extraction buffer (REF SB-R0187)
- Sterile swabs, each sealed in a plastic-paper pouch
- One package insert (instruction for use)
| CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
R0187S |
Influenza A/B Rapid Test (strip) CE |
25/kit |
Swab |